STRESSCALM- aconitum napellus whole, atropa belladonna, calendula officinalis flowering top, chelidonium majus whole, abrus precatorius seed, viburnum opulus bark tablet

StressCalm by

Drug Labeling and Warnings

StressCalm by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients** (in each tablet)

Aconitum napellus 6C HPUS (0.42 mg) (contains less than 10 -14 mg aconitine alkaloids)

Belladonna 6C HPUS (0.42 mg) (contains less than 10 -14 mg atropine alkaloids)

Calendula officinalis 6C HPUS (0.42 mg)

Chelidonium majus 6C HPUS (0.43 mg) (contains less than 10- 14 mg chelidonine alkaloids)

Jequirity 6C HPUS (0.4 mg) (contains less 10 -14 mg indole alkaloids)

Viburnum opulus 6C HPUS (0.4mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

Purpose*

Aconitum napellus 6C HPUS Relieves restlessness and agitation

Belladonna 6C HPUS Relieves hypersensitivity to stress

Calendula officinalis 6C HPUS Relieves nervous fatigue, hypersensitivity to noise

Chelidonium majus 6C HPUS Relieves digestive symptoms caused by stress

Jequirity 6C HPUS Relieves uneasiness

Viburnum opulus 6C HPUS Relieves nervousness and restless sleep

INDICATIONS & USAGE

Uses*

temporarily relieves symptoms of occasional stress such as:

• nervous tension
• fatigue
• digestive symptoms caused by stress
• hypersensitivity to stress or noise
• irritability, uneasiness

does not affect alertness

WARNINGS

STOP USE

Stop use and ask a doctor if symptoms persist for more than 2 weeks or worsen.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and older: At the onset of symptoms, dissolve 2 tablets under the tongue 3 times a day until symptoms are relieved.

Children under 12 years of age: Ask a doctor.

SPL UNCLASSIFIED SECTION

Do not use if glued carton end flaps are open or if the blister seal is broken.

store below 86°F (30°C)

contains 20 meltaway tablets unflavored

contains 60 meltaway tablets unflavored

contains 100 meltaway tablets unflavored

contains 120 meltaway tablets unflavored

Stress Relief*

Relieves Nervous Tension Calms Mind & Body*

Non-Drowsy

No known drug interactions

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

INACTIVE INGREDIENT

croscarmellose sodium, lactose, magnesium stearate

QUESTIONS

Questions or comments?

1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STRESSCALM 
aconitum napellus whole, atropa belladonna, calendula officinalis flowering top, chelidonium majus whole, abrus precatorius seed, viburnum opulus bark tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9333
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805)	VIBURNUM OPULUS BARK	6 [hp_C]
ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD)	ACONITUM NAPELLUS WHOLE	6 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_C]
ABRUS PRECATORIUS SEED (UNII: 3OM8I6L7CD) (ABRUS PRECATORIUS SEED - UNII:3OM8I6L7CD)	ABRUS PRECATORIUS SEED	6 [hp_C]
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	6 [hp_C]
CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS WHOLE - UNII:7E889U5RNN)	CHELIDONIUM MAJUS WHOLE	6 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	Boiron
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9333-04	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/14/2020
2	NDC: 0220-9333-29	1 in 1 PACKAGE	04/02/2021
2		120 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0220-9333-91	1 in 1 PACKAGE	07/13/2021
3		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0220-9333-92	5 in 1 BOX	03/21/2025
4		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/14/2020

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9333)